Date: 2014-09-08
Type of information: Presentation of results at a congress
phase:
Announcement: presentation of results at ERS International Congress 2014, the annual meeting of the European Respiratory Society.
Company: Bayer Healthcare (Germany)
Product: Adempas® (riociguat)
Action
mechanism: soluble guanylate cyclase (sGC) stimulator. Riociguat is a soluble guanylate cyclase (sGC) stimulator, the first member of a novel class of compounds, discovered and developed by Bayer as an oral treatment to target a key molecular mechanism underlying pulmonary hypertension. Riociguat is being investigated as a new and specific approach to treat different types of PH. sGC is an enzyme found in the cardiopulmonary system and the receptor for nitric oxide (NO). When NO binds to sGC, the enzyme enhances synthesis of the signaling molecule cyclic guanosine monophosphate (cGMP). cGMP plays an important role in regulating vascular tone, proliferation, fibrosis, and inflammation.
Disease: chronic thromboembolic pulmonary hypertension (CTEPH) pulmonary arterial hypertension (PAH)
Therapeutic area: Rare diseases - Cardiovascular diseases - Respiratory diseases
Country:
Trial details:
Latest
news: * On September 8, 2014, data presented at the European Respiratory Society (ERS) Congress confirm the safety profile and the sustained efficacy of Adempas® (riociguat) over at least two years of treatment in patients with inoperable chronic thromboembolic pulmonary hypertension (CTEPH) or persistent or recurrent CTEPH after surgical treatment, and in patients with pulmonary arterial hypertension (PAH). The two-year results of the open-label extension studies CHEST-2 and PATENT-2 confirm that the improvements in exercise capacity and WHO Functional Class (FC) as observed in the pivotal Phase III studies CHEST-1 and PATENT-1 were sustained. Exercise capacity as measured by the Six-Minute Walk Test is a marker of disease severity and a predictor of survival in patients suffering from PH. The longer observation time in CHEST-2 and PATENT-2 of at least two years allowed for an analysis of the correlation between efficacy endpoints and survival and clinical worsening, via a Cox proportional-hazards regression model. The model demonstrated a significant correlation between baseline values and change from baseline in 6 Minute Walking Distance (6MWD), N-terminal of the prohormone brain natriuretic peptide (NT-proBNP), WHO FC and event-free survival (no clinical worsening). The analysis of the CHEST-2 data cut-off showed that, at two years, mean exercise capacity of CTEPH patients as measured by the 6MWD had increased by 50m compared to CHEST-1 trial baseline. Moreover, WHO FC had improved or stabilized in 97% of CTEPH patients (39% improved and 58% stabilized). The survival rate of patients at two years of treatment with riociguat was 93%. In PATENT-2, PAH patients treated with riociguat over two years showed a mean improvement in 6MWD of 47m compared with PATENT-1 trial baseline. WHO FC had improved or stabilized in 91% of PAH patients (33% improved and 58% stabilized). As in CHEST-2, in PATENT-2 the survival rate of patients at two years of treatment with riociguat was 93%. Riociguat was generally well-tolerated, with a good safety profile. The most commonly reported adverse reaction, occurring in greater than or equal to 10 percent of patients under riociguat treatment (up to 2.5 mg TID), was dizziness. Other adverse reactions included dyspepsia, headache and hypotension. (Abstracts: Riociguat for the treatment of chronic thromboembolic pulmonary hypertension (CTEPH): 2-year results from the CHEST-2 long-term extension, Riociguat for the treatment of pulmonary arterial hypertension (PAH): 2-year results from the PATENT-2 long-term extension)
